Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
NCT Number: NCT07230600
The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.
Interested in participating?
Request Info22 year–45 year
Female
Interventional
Phase 1
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
Patients with refractory thin endometrium (endometrial thickness < 6 mm at late proliferative phase or after high-dose estrogen therapy) and/or moderate to severe intrauterine adhesion are recruited for fertility. After detailed explanation of the treatment plan, written informed consent will be obtained from the patients. The subjects undergo liposuction performed by plastic surgeons to obtain adipose tissue, from which AD-SVF is isolated and extracted for intrauterine infusion therapy. Six months post-AD-SVF treatment, the improvement in menstrual volume and endometrial thickness will be assessed during follow-up visits. The subjects will be advised, based on their personal inclination, to attempt conception (hysteroscopic surgery will be repeated if necessary), and their early pregnancy outcomes will be documented in subsequent follow-ups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
During the late proliferative phase, the endometrial thickness between anterior and posterior uterine walls is measured to be at least 6 mm through a median sagittal section of the uterus at least once.
Time frame: 2 months after AD-SVF intrauterine infusion therapy
2 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
6 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity at 6-8 weeks of gestation.
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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